Class 2 Device Recall ED PulseCheck

• Date Initiated by Firm: June 21, 2013
• Date Posted: July 29, 2013
• Recall Status: Terminated on December 19, 2014
• Recall Number: Z-1814-2013
• Recall Event ID: 65666
• Product Classification: Software, transmission & storage, patient data - Product Code NSX
• Product: Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
• Code Information: Software Versions 5.2 and 5.3
• Recalling Firm/ Manufacturer: Picis Inc.; 100 Quannapowitt Parkway; Suite 405; Wakefield MA 01880
• For Additional Information Contact: Support Representative; 781-557-3000
• Manufacturer Reason for Recall: Notes associated with prescription are not printed to the prescription or to the patient chart.
• FDA Determined Cause: Software change control
• Action: Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.
• Quantity in Commerce: 35
• Distribution: Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.